Cleared Traditional

WILDCAT CATHETER

K111338 · Avinger, Inc. · Cardiovascular

Aug 2011

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K111338 is an FDA 510(k) clearance for the WILDCAT CATHETER, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Avinger, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 11, 2011, 91 days after receiving the submission on May 12, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K111338 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2011
Decision Date	August 11, 2011
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PDU — Catheter For Crossing Total Occlusions
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.